Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022932
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-08-16
Brief Title:
Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Intermediate Grade Non-Hodgkins Lymphoma Following First Line CHOP
Sponsor:
Corixa Corporation
Organization:
Corixa Corporation
Study Overview
Official Title:
Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma Following First-Line CHOP
Status:
UNKNOWN
Status Verified Date:
2004-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and effectiveness of using Iodine-131 Anti-B1 Antibody for the treatment of patients with large B-cell non-Hodgkins lymphoma NHL who have achieved a response following 6-8 cycles of CHOP therapy
Detailed Description:
The primary endpoint is to determine the incidence of Grade IV hematologic toxicity following Iodine-131 Anti-B1 Antibody consolidation for patients with diffuse large B-cell NHL who achieved a response PR CRu CR following first-line CHOP chemotherapy The secondary efficacy endpoints are to determine the complete response rate duration of response duration of complete response progression-free survival and time to treatment failure The pharmacokinetic endpoint is to determine the total body residence time following the dosimetric dose The secondary safety endpoints are to determine the incidence of adverse experiences hematologic toxicity eg nadir time to nadir and time to recovery use of supportive care percent of patients converting to human anti-murine antibody HAMA positivity and survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None